By MedTech Intelligence Staff Unhappy with current textbooks and resources for regulatory professionals, Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston Scientific, authored his own book for industry and future regulators. |
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Sponsored By DistillerSR DistillerSR, in partnership with Citeline, surveyed global professionals in the medical device and in-vitro diagnostics industry to understand organizational preparedness and management maturity towards literature review practices. |
Featured Articles |
Regulatory Intelligence: By MedTech Intelligence Staff The increase in global regulatory demands for medical devices has presented new challenges for regulatory affairs and intelligence teams. On May 16-17, The MedTech Regulatory Intelligence Summit will bring together regulatory professionals, device developers and regulators to look at current trends in FDA and international pre-market and post-market requirements, as well as key pain points in achieving regulatory compliance throughout the product lifecycle. |
The Importance of High-Quality Communication in the Healthcare Setting By Chris Talbot, Spectralink Unified communication systems can improve staff efficiency, while enhancing patient outcomes and staff and patient safety. |
COMPLIMENTARY ON DEMAND WEBINAR |
Sponsored By HUMA.AI and Rimsys Post-market surveillance has become an increasingly important area of focus in both U.S. FDA and EU regulations. In this webinar, we take a closer look at the challenges of developing sustainable post-market surveillance processes, as well as how companies are addressing these challenges and using new tools to track product safety and performance post market. With Queenita Fernandes of Medtronic, Robert Di Giovanni of Novartis, Ashley Kelleher of NSF, Adam Price of Rimsys and Lana Feng of HUMA.AI. |
Integrating Games into Medical Devices To Improve Patient Outcomes By Lorenzo Gutierrez, Ph.D., StarFish Medical Imagine a patient undergoing therapy being relaxed and enjoying the treatment, or receiving rewards for taking medicine religiously and on time. Creating a game-like experience can change patient perception of medical devices from boring or scary to engaging and attractive. This article covers ways to integrate gaming features into your medical devices, why games are so enticing and how they impact human behavior. |
Featured Quote — Jeff Thompson, MD and Urvashi Bhatnagar |
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MedTech Library | |
Sponsored By Veeva Medtech Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business. |
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Sponsored By DNV This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates and standards publication. It also provides a review of requirements to be addressed in order to bring an SaMD to market. |
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MedTech Intelligence 2023 Washington DC Conferences More info at MedTechIntelligence.com May 16-17 May 18-19 November 7-8 November 8-9 |
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